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Clairvoyant currently executing a fully randomized multi-country Phase IIb clinical trial evaluating a synthetic psilocybin candidate as a potential therapeutic for Alcohol Use Disorder (AUD)
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Topline data from the ongoing Phase IIb AUD study anticipated in early 2025
NEW YORK, Sept. 06, 2024 — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today announced that the Company has entered into a conditional binding term sheet with privately-held Clairvoyant Therapeutics Inc (“Clairvoyant”), a clinical-stage developer of psilocybin-based therapeutics based in Canada, for the proposed acquisition by Psyence Biomed of 100% of the shareholdings of Clairvoyant (the “Proposed Acquisition”). As consideration for the Proposed Acquisition, Psyence Biomed will issue US$500,000 of the Company’s common shares upon closing to Clairvoyant’s disposing shareholders, followed by potentially up to two share-based payments of US$250,000 each (payable in cash or common shares, at the Company’s election) upon the achievement of pre-specified milestones by December 2026. In addition, Psyence Biomed will advance funds in tranches of up to US$1,800,000 in aggregate to Clairvoyant in order to settle its liabilities, which consist primarily of clinical trial costs.
Clairvoyant is currently executing a Phase IIb clinical trial (CLA-PSY-201) of a synthetic psilocybin-based candidate as a potential treatment for Alcohol Use Disorder (AUD). The company has completed the enrollment and treatment of 154 randomized double blinded subjects and topline results are anticipated in early 2025.
“The proposed acquisition of Clairvoyant makes strategic sense for us for several reasons,” said Dr. Neil Maresky, Chief Executive Officer of Psyence Biomed. “First, it introduces a synthetic psilocybin-based therapeutic candidate that nicely compliments our ongoing nature-derived psilocybin development program that we are advancing in Adjustment Disorder following a life limiting cancer diagnosis in the Palliative Care context. Additionally, this proposed acquisition may expand our pipeline into another high-value indication – AUD – with a regulatory pathway that could potentially transition us to a commercial-stage, revenue-generating company.”
“With this proposed acquisition, we would have line-of-sight to two important Phase II data read-outs that, if successful, would position us as a leader in the development of psychedelic-based therapeutics to treat a range of underserved mental health and related disorders that are in need of effective new treatment options,” Dr. Maresky concluded.
“We are very pleased to join forces with Psyence Biomed as we move ahead with our ‘speed to market’ strategy for psilocybin in AUD,” stated Damian Kettlewell, Chief Executive Officer of Clairvoyant. “AUD has the widest treatment gap among all mental health disorders; while 15%1,2,3 of adult drinkers in the EU, Canada and the UK – 50 million people – are considered to be at risk for AUD, fewer than 1%4,5 seek any form of drug therapy, and currently approved therapeutics are plagued by modest efficacy and poor compliance.”
Mr. Kettlewell added, “Importantly, prior academic studies, including one study by NYU Langone published in JAMA Psychiatry in 20226, found that psilocybin-assisted psychotherapy resulted in an 83% average reduction in alcohol consumption. As well, a study of psilocybin therapy for AUD from August 2024 showed that a single psilocybin dose was safe and effective in reducing alcohol consumption in AUD patients7. These two studies suggest that there is very strong scientific rationale for continued development in this indication.”
“We look forward to topline data in early 2025 that, if positive, could accelerate development plans to approval.”
Clairvoyant’s Phase IIb clinical trial is a 24-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study evaluating two administrations of 25mg psilocybin (at weeks five and nine) in conjunction with psychotherapy compared to placebo. Twelve study sites in E.U. and Canada are participating in the trial, which randomized 154 subjects with a moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator. All study subjects expressed a desire to reduce or stop alcohol consumption.
The Proposed Acquisition shall be subject to the conclusion of a definitive share purchase agreement between the parties based on the salient terms set out in the binding term sheet. The completion of the Proposed Acquisition is subject to several suspensive conditions, including board approval, regulatory strategy approvals, and satisfactory due diligence, as well as such other customary closing conditions.
For more information on the Clairvoyant Phase II trial: https://clinicaltrials.gov/study/NCT05646303
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company focused on the development of botanical (nature-derived and non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Psyence is initially focused on mental health disorders in the context of Palliative Care.
Learn more at www.psyencebiomed.com and on LinkedIn.
